在产后抑郁症中注射布雷克萨诺:两个多中心,双盲,随机,安慰剂对照的3期试验
Samantha Meltzer-Brody1, Helen Colquhoun2, Robert Riesenberg3
1Department of Psychiatry, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
Lancet (London, England)
|September 5, 2018
概括
在两个第三阶段试验中,布雷克萨诺注射显著降低了产后抑郁症症状. 这种GABAA受体调节剂为患有中度至重度产后抑郁症的妇女提供了一种新疗法.
科学领域:
- 神经科学
- 精神病学
- 药理学
背景情况:
- 产后抑郁症是致病的重要原因,需要改善药物治疗.
- 布雷克萨诺隆注射是一种GABAA受体的阳性异质调节剂,被研究用于PPD治疗.
研究的目的:
- 评估布雷克萨诺注射治疗中度至重度产后抑郁症的疗效和安全性.
主要方法:
- 分别对138名和108名妇女进行了双盲,随机,安慰剂控制的第三期试验.
- 参与者接受了静脉内布雷克萨诺 (60或90μg/ kg/ h) 或安慰剂,持续60小时.
- 主要终点是60小时后汉密尔顿抑郁评分表 (HAM- D) 总得分的变化.
主要成果:
- 与安慰剂相比,在两项研究中,布雷克萨诺注射在60小时内显示出具有统计学意义和临床意义的HAM- D得分降低.
- 在整个研究期间观察到快速减少,持续效应.
- 常见的不良反应包括头痛,头和昏昏欲睡;严重的不良反应很少发生.
结论:
- 布雷克萨诺隆注射为产后抑郁症提供了一种新疗法, 显示出快速而持久的疗效.
- 这种药物有可能改善患有这种疾病的妇女的治疗结果.
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